A Phase 2, Multicenter, Open Label, Non-randomized Study to Evaluate the Efficacy and Safety of Extended Dosing of Belantamab Mafodotin in Different Combinations With Standard of Care Regimens in Participants With Relapsed-refractory Multiple Myeloma (DREAMM-15)

This study is for adults with multiple myeloma (a type of blood cancer) that has come back after being treated earlier or isn't responding to the current treatment.
The main goal is to find out if the study drug, belantamab mafodotin, given less often (on an extended schedule) with other cancer medicines, can still treat the cancer effectively while causing fewer side effects, especially those affecting the eyes. The study will also look at how well the treatment works overall and how safe it is when administered to the participants.

开始日期2026-01-14

申办/合作机构

GSK Plc

NCT07224672

/ Not yet recruiting临床2期

A Phase 2, Open-label, Single-arm, Proof-of-concept Study Evaluating the Efficacy and Safety of Belantamab Mafodotin Administered in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain Amyloidosis (ALANIS)

The study aims to evaluate the efficacy and safety of belantamab mafodotin in combination with cyclophosphamide, bortezomib, and dexamethasone in adult participants with newly diagnosed (ND) AL amyloidosis .

开始日期2025-12-01

申办/合作机构

GSK Plc

NCT05874193

/ Not yet recruiting临床2期IIT

A Collaborative Community Effort Using Belantamab Mafodotin in Relapsed/Refractory Myeloma

This is a research study to find out if a drug called belantamab mafodotin in combination with dexamethasone, a steroid, can be safely and effectively given in the community setting. Belantamab mafodotin (BLENREP) was approved in the US in August 2020 under an FDA program called accelerated approval. In November 2022, belantamab mafodotin was removed from the market because a study to further confirm its activity in relapsed/refractory multiple myeloma did not deliver a supporting result. However, this confirmatory study demonstrated that some patients may still benefit from treatment with belantamab mafodotin, and that this benefit can be long lasting. Belantamab mafodotin is often given at large academic medical centers every 3 weeks. This study will assess whether it is possible to administer belantamab in the community setting every 6 weeks. It is unknown if administering belantamab every 6 weeks versus every 3 weeks will result in improved safety and/or reduced efficacy.

开始日期2025-10-01

申办/合作机构

Duke University

100 项与玛贝妥单抗相关的临床结果

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100 项与玛贝妥单抗相关的转化医学

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100 项与玛贝妥单抗相关的专利（医药）

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299

项与玛贝妥单抗相关的文献（医药）

2025-11-25·Blood Advances

Modification of belantamab mafodotin dosing to balance efficacy and tolerability in the DREAMM-7 and DREAMM-8 trials

Article

作者: Cerchione, Claudio ; Ho, P. Joy ; Paka, Prani ; Aparecida-Martinez, Gracia ; Suzuki, Kazuhito ; Pour, Ludek ; Rogers, Rachel ; Trudel, Suzanne ; Robak, Paweł ; Lewis, Eric ; Kim, Kihyun ; Opalinska, Joanna B. ; Wilkes, Jodie ; Mateos, María-Victoria ; Beksac, Meral ; Phillips-Jones, Amy ; Hus, Marek ; Ward, Christopher ; Spicka, Ivan ; Sule, Neal ; Dimopoulos, Meletios Athanasios ; Radocha, Jakub ; Cavo, Michele ; Delimpasi, Sosana ; Fu, Chengcheng ; Vorobyev, Vladimir ; Wang, Zhaohui ; Hungria, Vania ; Baig, Hena ; Pitombeira de Lacerda, Marcelo ; Eccersley, Lydia ; Zhou, Xiaoou L. ; Quach, Hang ; Zherebtsova, Vera ; Jelínek, Tomas ; Mukhopadhyay, Pralay

Abstract:

Belantamab mafodotin (belamaf) combined with standard therapies demonstrated significant progression-free survival (PFS) and overall survival benefits in DREAMM-7 and PFS benefit in DREAMM-8 in relapsed/refractory multiple myeloma. Belamaf dose modifications managed adverse events, including belamaf-related ocular events. Ocular events included ocular adverse reactions (eg, dry eyes, photophobia, eye irritation) and protocol-mandated ophthalmic examination findings. Protocol-recommended dose modifications for ocular events were driven by ophthalmic examination findings and included belamaf dose delays until resolution and reductions. We used descriptive analyses to evaluate the impact of dose modifications on managing ocular events and treatment efficacy. In patients with normal baseline vision who were receiving treatment, dose modifications extended belamaf dosing intervals to a median of 8 to 12 weeks by 9 months; the prevalences of reduced vision to bilateral 20/50 or worse and ocular adverse reactions were highest in the first 3 months and remained low at later time points. The median time to resolution after grade ≥2 ophthalmic examination findings was 12 weeks. Rates of belamaf discontinuations due to ocular events were low. Almost all responders (partial response or better) required dose modifications. Most patients achieved a response before an extended (>2 cycles) dose delay; most who had not, subsequently achieved or deepened their response. In DREAMM-7 and DREAMM-8, the median PFS in patients with ≥1 dose delay of ≥12 weeks was 36.6 months and not reached, respectively. Ocular events were common but effectively managed with dose modifications, allowing for patients to remain on treatment and derive robust efficacy benefit. The trials were registered at www.clinicaltrials.gov as #NCT04246047 (DREAMM-7) and #NCT04484623 (DREAMM-8).

2025-11-01·Lancet Haematology

Patient-reported outcomes with belantamab mafodotin, pomalidomide, and dexamethasone versus bortezomib, pomalidomide, and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-8): a phase 3, open-label, randomised controlled trial

Article

BACKGROUND:

In the DREAMM-8 trial, belantamab mafodotin, pomalidomide, and dexamethasone demonstrated a statistically significant reduction in the risk of progression or death compared with bortezomib, pomalidomide, and dexamethasone in lenalidomide-exposed patients with relapsed or refractory multiple myeloma. We present patient-reported outcomes from this trial.

METHODS:

This phase 3, open-label, randomised controlled trial was done in 95 sites in 18 countries. Eligible patients were adults aged 18 years or older with relapsed or refractory multiple myeloma per International Myeloma Working Group criteria, an Eastern Cooperative Oncology Group performance status of 0-2, and previous treatment with at least one line of therapy that included lenalidomide. Patients were randomly assigned (1:1) by a central interactive response technology system to receive 28-day cycles of intravenous belantamab mafodotin (2·5 mg/kg on day 1 of cycle 1 and 1·9 mg/kg on day 1 of cycle 2 onward) combined with oral pomalidomide (4 mg on days 1 to 21) and oral dexamethasone (40 mg on days 1, 8, 15, and 22; belantamab mafodotin group) or 21-day cycles of subcutaneous bortezomib (1·3 mg/m² on days 1, 4, 8, and 11 of cycles 1-8 and days 1 and 8 of cycle 9 onward) combined with pomalidomide and dexamethasone at the same doses and schedules as the belantamab mafodotin group; bortezomib group). Treatment continued until the occurrence of progressive disease, unacceptable adverse effects, withdrawal of consent, or death (whichever occurred first). Secondary patient-reported outcome endpoints were change from baseline in health-related quality of life (HRQOL), measured by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, EORTC QLQ-MY20, and Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE). Ocular Surface Disease Index and Functional Assessment of Chronic Illness Therapy-Item GP5 results were assessed similarly as exploratory endpoints. EORTC QLQ-C30 and EORTC QLQ-MY20 disease symptom domain results were analysed in the intent-to-treat population, and PRO-CTCAE results were analysed in the safety population (patients who received at least one dose of study treatment). For all patient-reported outcome assessments, proportions included the number and percentage of patients with available data, and changes from baseline were summarised as means with 95% CIs at each timepoint. This trial was registered with ClinicalTrials.gov, NCT04484623, and is ongoing.

FINDINGS:

Between Oct 12, 2020, and Dec 26, 2022, 382 patients were assessed for eligibility. 80 patients were excluded and 302 patients were enrolled and randomly assigned to either the belantamab mafodotin group (n=155) or bortezomib group (n=147). The median age in the whole population was 66·1 years (SD 9·31). 181 (60%) of 302 patients were male and 260 (86%) were White. At the primary analysis data cutoff (Jan 29, 2024), median follow-up was 21·8 months (IQR 13·2-27·6). For all patient-reported outcome assessments during treatment, compliance was at least 90% for most visits within the first year. Change from baseline in EORTC QLQ-C30 and QLQ-MY20 domain scores remained stable in both treatment groups over time, with a consistently greater proportion of patients in the belantamab mafodotin group than in the bortezomib group experiencing meaningful improvement (≥10 points) at most visits. Side-effects were minimally bothersome in both groups within the first year of treatment. Blurred vision was the adverse event most commonly reported as severe or very severe (63 [43%] of 146 patients in the belantamab mafodotin group and 13 [9%] of 139 patients in the bortezomib group), followed by fatigue (56 [38%] of patients in the belantamab mafodotin group and 49 [35%] of patients in the bortezomib group). No clear differences between groups were observed for other symptomatic adverse events.

INTERPRETATION:

Patients with relapsed or refractory multiple myeloma treated with belantamab mafodotin, pomalidomide, and dexamethasone or bortezomib, pomalidomide, and dexamethasone reported stable HRQOL. Self-reported ocular adverse events were generally manageable and minimally bothersome within the first year of treatment. These findings indicate that belantamab mafodotin, pomalidomide, and dexamethasone is well tolerated, with little detriment to HRQOL, supporting its use in relapsed or refractory multiple myeloma.

FUNDING:

GSK.

2025-10-03·EXPERT OPINION ON BIOLOGICAL THERAPY

Belantamab mafodotin for the treatment of multiple myeloma

Review

作者: Loscos, Jordi ; Oriol, Albert ; Abril, Laura ; Ibarra, Gladys

INTRODUCTION:

Advances in frontline multiple myeloma (MM) treatment, through combinatorial regimens with diverse mechanisms of action, have created a need for alternative agents at relapse. BCMA-targeting CAR-T therapies have already demonstrated superiority over conventional options. Belantamab mafodotin, a first-in-class BCMA-directed antibody - drug conjugate (ADC), has shown significant benefit in combination with proteasome inhibitors or immunomodulators, as an accessible alternative to CAR-T therapy.

AREAS COVERED:

Belantamab mafodotin-based regimens were approved for the treatment of MM from second line of therapy in UK (April 2025) and EU (July 2025) and is under extended review by the FDA after concerns raised regarding its safety profile. This review discusses its mechanism of action, along with efficacy and safety data, to evaluate its role in the evolving MM treatment landscape.

EXPERT OPINION:

Belantamab mafodotin offers a distinct therapeutic profile: off-the-shelf availability compared to CAR-Ts, lower infection risk than T-cell engagers, and a mechanism of action distinct from both T-cell - redirecting and standard therapies. Ocular keratopathy is a class-specific adverse event that is manageable with appropriate measures. Its relatively low incidence of life-threatening infections supports its use, particularly in frail patients. Ongoing trials suggest a feasible integration into frontline regimens to further improve clinical outcomes.

500

项与玛贝妥单抗相关的新闻（医药）

2025-11-19

·人世间事儿

10月全球十大医疗医药动态

以下是2025年10月全球十大医疗医药动态，聚焦新药获批、临床进展、行业合作等核心领域，具体如下：1. 中国启动新一轮创新药物研发国家科技重大专项：10月26日，新一轮“创新药物研发国家科技重大专项”正式启动。该专项拟实现跨越式发展，目标是到2035年建成国家药物创新体系，让全链条新药研发综合创新能力跻身世界第一梯队。2. 乐普生物首款EGFR靶向ADC获批上市：10月30日，乐普生物的维贝柯妥塔单抗获NMPA附条件批准，用于治疗复发性或转移性鼻咽癌。其在相关临床试验中显著降低37%的疾病进展或死亡风险，还计划进一步拓展适应症。3. 拜耳首款双重神经激肽受体拮抗剂获FDA批准：10月24日，拜耳的Lynkuet胶囊获美国FDA批准上市，用于治疗绝经相关的中度至重度潮热。这款非激素类疗法是首款获批的双重神经激肽受体拮抗剂，且3期临床试验均达成主要终点。4. 信达生物与武田制药达成全球战略合作：10月21日，信达生物与武田制药签约，共同推进下一代IO+ADC疗法全球开发和商业化。针对不同合作药物，双方将按约定分担成本或划分独家商业化权益等。5. 罗氏奥妥珠单抗获批狼疮性肾炎新适应症：10月20日，罗氏的奥妥珠单抗获FDA批准用于治疗活动性狼疮性肾炎成人患者，它也是首个获FDA批准用于该病症的CD20靶向疗法，临床试验中其联合标准治疗的完全肾脏缓解率显著更高。6. 勃林格殷格翰首款肺纤维化疗法在华获批：10月22日，勃林格殷格翰的那米司特片获NMPA批准，用于治疗成人特发性肺纤维化。作为首款PDE4B抑制剂，其相关III期研究是十年来首个达到主要终点的IPF III期临床研究。7. 葛兰素史克BCMA ADC联合疗法获批治疗多发性骨髓瘤：10月23日，GSK的抗体偶联药物Blenrep联合疗法获FDA批准，用于治疗至少接受过两种既往疗法的复发或难治性多发性骨髓瘤，该联合方案能将患者死亡风险降低51%。8. 安斯泰来与辉瑞联合疗法获FDA优先审评资格：10月22日，双方合作的Padcev联合Keytruda的补充生物制品许可申请获FDA受理并纳入优先审评，拟用于特定肌层浸润性膀胱癌患者治疗，临床试验中该方案可大幅降低复发、进展或死亡风险。9. Moderna终止CMV mRNA疫苗研发：10月22日，Moderna宣布终止CMV mRNA疫苗mRNA-1647的开发。这款核心管线疫苗的三期临床试验未达到预防CMV感染的主要终点，该试验入组约7500例受试者，是迄今最大的CMV疫苗临床试验。10. 第一三共TA-MUC1靶向ADC临床试验显积极活性：10月19日，第一三共公布DS-3939的1/2期临床试验初步数据。这款TA-MUC1靶向ADC在晚期实体瘤患者中展现出积极临床活性，观察到1例完全缓解和10例部分缓解。

优先审批临床3期疫苗抗体药物偶联物上市批准

2025-11-17

·生物制品圈

2025 生命科学领域最具影响力的十大女性

尽管生命科学领域女性高管占比仍偏低（女性首席执行官比例约 8%），但众多女性正打破职业壁垒，在制药、生物技术等领域推动创新。以下是 2025 年该领域最具影响力的 10 位女性，她们以科研突破、企业领导力和行业赋能为核心贡献，重塑行业发展格局。巴希贾・贾拉勒博士（Immunocore） 2019 年接手濒临绝境的免疫核心公司后，贾拉勒半年内完成 1.3 亿美元 B 轮融资，推动公司 2021 年纳斯达克上市。她带领团队研发的 Kimmtrak 获批上市，成为全球首款 TCR 疗法，为转移性葡萄膜黑色素瘤患者带来新希望。目前团队正拓展疗法至传染病和自身免疫性疾病领域，包括艾滋病功能性治愈候选药物，同时她注重团队多样性与协作，搭建包容的创新环境。芭芭拉・萨苏博士（Dispatch Bio）拥有十多年肿瘤学研究经验，从安进离职后转向实体瘤治疗领域，现任 Dispatch Bio 首席科学官。带领团队开发基于 Flare 通用抗原的免疫疗法平台，通过标记实体瘤细胞激活免疫系统，聚焦 CAR-T 细胞疗法及联合治疗方案。她重视导师传承，以协作式管理风格培养团队，助力小型生物公司实现技术突破。克里斯汀・罗博士（Nimbus Therapeutics）从哈佛医学院获得免疫学博士学位后，放弃学术道路投身生物制药行业。历经礼来、辉瑞等企业历练后，加入尼姆布斯治疗公司，主导肿瘤学、肝病等多领域研发。推动公司以跨部门沟通机制（如补贴午餐交流）打破协作壁垒，同时为团队成员提供科研管理与业务能力双重培训，目标未来担任首席科学官。卡拉・伊根（Teal Health）凭借健康科技行业经验，发现宫颈癌筛查技术的市场空白，与合作伙伴优化居家采样设备。历时五年打造首款 FDA 批准的居家宫颈癌筛查试剂盒 Teal Wand，注重产品舒适度与女性用户体验，传递 “女性医疗服务专属化” 理念。在公司管理中倡导打破性别刻板印象，以坦诚透明风格带领团队突破医疗技术监管瓶颈。劳拉・兰德 - 迪纳博士（Jefferson Life Sciences）拥有表观遗传学博士学位，从哈佛研究员转型为投资高管，现任杰斐逊生命科学公司管理合伙人。擅长跨领域创新，将非生命科学行业模式应用于生物技术投资，参与创办人工智能药物研发公司 Valo Health。推动麻省理工学院 “教员创始人计划”，助力女性科研人员实现成果商业化，坚持回馈行业生态。莉娜・波利梅尼（礼来公司）以销售岗位入职礼来，晋升为首席消费者营销官，主导公司百年首个企业级营销活动 “一家制药公司”。将军事战略思维与人文关怀融入管理，打造 “女性职业发展路径模型”，推动管理层性别平等。通过奥运会、奥斯卡等场景植入品牌，让医疗品牌自然融入大众生活，同时鼓励团队平衡工作与自我滋养。玛雅・马丁内斯 - 戴维斯（葛兰素史克）现任葛兰素史克美国业务总裁，六年内推动四款新药成功上市，包括骨髓瘤药物 Blenrep 的市场复苏。从柯达销售转型制药行业，深耕肿瘤学领域，秉持 “以患者为中心” 的使命感，重视一线团队反馈与跨部门协作。在导师贝伦・加里霍指引下成长，聚焦药物可及性与预防价值，应对美国医药政策复杂环境。米内塔・刘博士（Natera）深耕液体活检领域数十年，从学术医疗转向企业界，现任纳特拉公司肿瘤学首席医疗官。推动细胞游离 DNA 检测技术临床应用，主导的膀胱癌伴随诊断试剂正接受 FDA 审批，有望实现癌症早期精准监测。呼吁行业加速女性 STEM 领域晋升，以自身经历为女性科研人员提供指导与支持。纳贾特・汗博士（Recursion Pharmaceuticals）受医疗行业童年经历与家人病患影响，深耕药物研发创新。凭借计算化学专业与咨询行业经验，推动强生将 AI 纳入战略核心，2024 年加入递归制药后，全面负责药物研发与商务业务，2026 年初将升任首席执行官。倡导打破行业常规，打造跨学科人才团队，以 AI 革新药物研发模式。雷什玛・凯瓦尔拉马尼博士（Vertex Pharmaceuticals）从临床医生转型制药行业，2020 年成为美国大型生物技术公司首位女性首席执行官。带领福泰制药实现多项突破，包括首款 CRISPR 基因编辑疗法 Casgevy、非阿片类止痛药 Journavx 获批上市，公司营收预计 2025 年达 119-120 亿美元。推动公司拓展神经系统、血液疾病等研发管线，通过实习与实验室项目培育行业新生代人才，呼吁填补女性领导力机会缺口。行业数据显示，女性在生命科学基层从业者中占比超男性，但高管层占比不足，56% 受访者认为男性职业发展更具优势。尽管存在系统性障碍，这些女性领导者仍以科研突破、企业治理与行业赋能为核心，持续推动生命科学领域的创新与平等。参考来源：https://www.fiercepharma.com/pharma/2025s-fiercest-women-life-sciences 识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

细胞疗法免疫疗法上市批准诊断试剂

2025-11-17

·醉心科学

醉心资讯 NO.202510 | 产业市场

关注醉心科学，聚焦干细胞领域研究进展醉心资讯以干细胞与再生医学领域综合信息跟踪和报道为主，围绕干细胞和再生医学领域创新研究主题开展编译报道和分析研究。 “战略与政策”栏目编译报道干细胞与再生医学国内外重要战略、政策、举措和项目部署方面的信息综述；“研究进展”栏目报道领域国内外科学技术前沿研究动态信息；“产业市场”栏目报道领域产品与服务应用及产业市场发展动态信息。产业市场产业发展1.BlueRock Therapeutics启动干细胞衍生疗法OpCT-001首次人体临床试验2.GSK旗下Blenrep获美国FDA批准用于治疗多发性骨髓瘤3.Qureator宣布完成全球首个基于人类血管化类器官体外数据的FDA IND评审4.武汉光谷中源药业人脐带源间充质基质细胞注射液临床IND获批市场动态5.BMS以15亿美元收购体内CAR-T公司Orbital Therapeutics6.Rarity PBC完成460万美元种子轮融资推进基因疗法开发7.iOrganBio携CellForge平台获200万美元种子轮融资 01 BlueRock Therapeutics启动干细胞衍生疗法OpCT-001首次人体临床试验 2025年10月7日，拜耳（Bayer）的子公司BlueRock Therapeutics宣布，其在研的诱导多能干细胞（iPSC）衍生疗法OpCT-001已在I/Ⅱ期CLARICO临床试验（NCT06789445）中完成了首位患者给药。这项试验开创了先河，是全球首个针对原发性光感受器疾病患者群体的iPSC衍生细胞疗法临床研究，为包括视网膜色素变性和视锥视杆细胞营养不良在内的遗传性视网膜疾病患者带来了新的希望。 CLARICO试验是一项在多中心展开的、分为两部分的人体首次介入性研究，旨在评估OpCT-001在约54名成年原发性光感受器疾病患者中的安全性、耐受性和初步疗效。其具体情况如下。入组标准：参与者需有基因确诊的原发性光感受器疾病，并满足特定的视力（BCVA）和视网膜结构要求。 I期研究（安全性与剂量探索）：此阶段将招募12至24名法定盲人参与者，分为四个队列，接受四种不同剂量的OpCT-001治疗。研究将采用标准的3+3剂量递增模式，主要评估药物的安全性。 II期研究（安全性与疗效评估）：此阶段将进一步收集安全性数据，并重点评估OpCT-001对视觉功能、功能性视力以及视网膜细胞植入的解剖学指标的影响。研究将根据I期数据选定两个最佳剂量水平，招募最多15名参与者，并进行随机分配。标题：iPSC细胞疗法OpCT-001进入人体试验，能否逆转视网膜色素变性等遗传性眼病？来源：https://medfind.link/info/38466 原文标题：BlueRock Therapeutics reports positive 36-month results from Phase I trial of bemdaneprocel for treating Parkinson’s disease 原文链接：https://www.bayer.com/media/en-us/bluerock-therapeutics-reports-positive-36-month-results-from-phase-i-trial-of-bemdaneprocel-for-treating-parkinsons-disease/ 02 GSK旗下Blenrep获美国FDA批准用于治疗多发性骨髓瘤 2025年10月23日，葛兰素史克（GSK）宣布其药物Blenrep（belantamab mafodotin-blmf）联合硼替佐米和地塞米松（BVd）获美国FDA批准，用于治疗至少接受过两种先前疗法（包括蛋白酶体抑制剂和免疫调节剂）的复发或难治性多发性骨髓瘤成人患者。该批准基于关键DREAMM-7 Ⅲ期试验数据。结果显示，在接受过至少三线治疗的患者中，BVd组合可使死亡风险降低51%（HR 0.49），中位无进展生存期（PFS）达31.3个月，是达雷妥尤单抗三联疗法（DVd）的3倍（10.4个月）。安全性方面，组合疗法的耐受性与各单药已知特性一致。为优化患者安全与用药便利性，GSK与FDA合作推出了简化版风险评估与缓解策略（REMS），通过精简患者表格、移除重复检查项及优化眼科监测沟通流程，降低行政负担。同时，GSK推出“Together with GSK”患者支持项目，提供保险协助、费用管理及持续教育服务。 DREAMM临床试验数据将提交至美国国家综合癌症网络（NCCN）指南。目前，Blenrep已在欧盟、英国、日本等多国获批，中国上市申请获突破性疗法认定并正在优先审评中。GSK正在推进DREAMM系列试验，计划2028年公布早期治疗线及总生存期数据，并扩大美国患者入组范围，以加速全球患者可及性。原文标题：Blenrep approved by US FDA for use in treatment of relapsed/refractory multiple myeloma 原文链接：https://www.businesswire.com/news/home/20251023707077/en/Blenrep-approved-by-US-FDA-for-use-in-treatment-of-relapsedrefractory-multiple-myeloma 03 Qureator宣布完成全球首个基于人类血管化类器官体外数据的FDA IND评审 2025年10月27日，美国圣地亚哥Qureator公司宣布完成全球首个基于人类血管化类器官体外数据的FDA新药临床申请（IND）评审，标志着《FDA现代化法案2.0》框架下药物研发模式的根本性变革。这是首个完全依赖人类相关模型获得FDA IND批准的肿瘤学案例。此次获批依托Qureator自主研发的AI驱动型vTIME（血管化肿瘤免疫微环境）类器官芯片平台。该平台生成的关键临床前数据，助力合作伙伴SillaJen公司成功推进其联合疗法BAL0891与免疫检查点抑制剂的临床开发进程。FDA此次决策印证了该技术平台在预测人体疗效方面的显著优势，较传统动物模型更具临床转化价值。该突破性进展同时获得韩国食品药品安全部（MFDS）认可，进一步巩固了Qureator在下一代临床前平台领域的全球领导地位。此案例为全球药物研发领域提供了可复制的监管新范式，预示着以患者为中心的精准药物开发时代正式开启。原文标题：Qureator Achieves World’s First FDA IND Approval Using Only Human Vascularized Organoid Efficacy Data 原文链接：https://qureator.com/qureator-achieves-worlds-first-fda-ind-approval-using-only-human-vascularized-organoid-efficacy-data/ 04 武汉光谷中源药业人脐带源间充质基质细胞注射液临床IND获批 2025年10月30日，中源协和细胞基因工程股份有限公司全资子公司武汉光谷中源药业有限公司收到国家药品监督管理局核准签发的关于VUM02注射液用于治疗肺炎后进展性肺纤维化的《药物临床试验批准通知书》。 VUM02注射液（人脐带源间充质基质细胞注射液）是武汉光谷中源药业自主研发的冷冻保存型细胞制剂，是由经筛选的健康新生儿脐带组织通过体外分离、扩增、收获、冻存后制备的人脐带源间充质基质细胞（UC-MSCs）新药，临床拟用适应症增加肺炎后进展性肺纤维化的治疗。截至目前，VUM02注射液10个适应症获批IND，分别临床拟用于治疗失代偿期肝硬化、特发性肺纤维化、慢加急性（亚急性）肝衰竭及中、重度急性呼吸窘迫综合征、重型/危重型新型冠状病毒感染、激素治疗失败的Ⅱ度至Ⅳ度急性移植物抗宿主病、系统性硬化症、活动期中重度溃疡性结肠炎、重型/危重型肺炎、肺炎后进展性肺纤维化。VUM03注射液1个适应症获批IND，拟用于治疗非活动性/轻度活动性克罗恩病、复杂性肛瘘。原文标题：好消息！我国细胞新药（人脐带源间充质基质细胞注射液）临床IND获批！目前公司细胞药物已有11个适应症获批临床IND 原文链接：https://mp.weixin.qq.com/s/2DT7Lwlz7gD0SHgEHBj_7Q 05 BMS以15亿美元收购体内CAR-T公司Orbital Therapeutics 2025年10月10日，百时美施贵宝公司（BMS）和Orbital Therapeutics（Orbital）宣布了一项最终协议——BMS将收购Orbital。 Orbital是一家私营生物技术公司，率先开发新一代RNA药物，该药物可在体内重新编程免疫系统，从而提供解决每种疾病的潜在生物学和独特复杂性所需的精确度、控制力和灵活性的治疗方法。此次收购包括Orbital公司领先的RNA免疫疗法临床前候选药物OTX-201，该药物目前正在进行IND申报研究。OTX-201包含一种优化的环状RNA，编码一种靶向CD19的CAR，可通过靶向脂质纳米颗粒（LNP）递送至体内表达。这种体内疗法利用患者自身作为CAR-T细胞的制造者，与体外CAR-T细胞疗法相比，有望减轻治疗负担，提高可及性。此外，BMS还将收购Orbital公司专有的RNA平台，该平台集成了环状和线性RNA工程、先进的LNP递送技术和AI驱动的设计，从而能够针对多种疾病的独特生物学特性，定制化持久、可编程的RNA疗法。原文标题：Bristol Myers Squibb Strengthens and Diversifies Cell Therapy Portfolio with Acquisition of Orbital Therapeutics 原文链接：https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Strengthens-and-Diversifies-Cell-Therapy-Portfolio-with-Acquisition-of-Orbital-Therapeutics/default.aspx 06 Rarity PBC完成460万美元种子轮融资推进基因疗法开发 2025年10月29日，致力于罕见病疗法开发的公司Rarity PBC宣布完成460万美元种子轮融资，由生物科技投资者Steve Oliveira领导的Nemean资产管理公司领投。融资将用于加速其主导项目——针对腺苷脱氨酶严重联合免疫缺陷（ADA-SCID）的一次性自体造血干细胞基因疗法的开发。该疗法源于加州大学洛杉矶分校（UCLA）Donald B. Kohn博士与伦敦大学学院合作研发的专利技术。在已发表的试验及长期随访中，该疗法在62例接受治疗的儿童中实现59例免疫功能持久重建，目前已有超70名患者受益。Rarity已通过UCLA技术发展集团获得该疗法的独家授权，并计划推进美国FDA审批及商业化生产。原文标题：Rarity PBC Raises $4.6 Million Seed Financing to Advance Gene Therapy for ADA-SCID 原文链接：https://www.businesswire.com/news/home/20251029335528/en/Rarity-PBC-Raises-%244.6-Million-Seed-Financing-to-Advance-Gene-Therapy-for-ADA-SCID 07 iOrganBio携CellForge平台获200万美元种子轮融资 2025年10月30日，生物科技初创企业iOrganBio正式宣布完成200万美元种子轮融资，由First Star Ventures领投，IndieBio、Cape Fear BioCapital等机构跟投。该公司于2024年由曾任多家生命科学技术公司高管的Daniel Delubac博士、威尔康奈尔医学院陈水冰博士及MD安德森癌症中心沈西凌教授联合创立，聚焦通过AI与自动化技术革新细胞制造产业。其核心产品CellForge平台是首个AI驱动的规模化人体细胞及类器官工程系统，集成预测性机器学习算法与高通量实时控制技术，可实时动态调整3D培养环境参数，实现人源多能干细胞分化过程的精准控制。平台依托自主研发的“功能型人类细胞图谱”数据库，该数据库整合单细胞及多组学数据，支持跨应用场景的细胞类型定制化生产。技术突破点体现在解决细胞研发五大核心挑战：通过数字化定义细胞特征提升可定义性；支持多样化细胞类型生产增强通用性；兼容多来源细胞原料强化适应性；通过闭环AI控制确保批次间高重现性；配合自动化流程实现从实验室到工业级生产的无缝扩增。平台已在胰腺类器官模型构建中验证了其血管化及免疫微环境定制能力，展现出在疾病建模与再生医学领域的广泛应用潜力。原文标题：iOrganBio: $2 Million Raised For Developing AI-Based Cell Manufacturing Solutions 原文链接：https://pulse2.com/iorganbio-2-million-raised-for-developing-ai-based-cell-manufacturing-solutions/ 点击关注关注醉心科学聚焦干细胞领域研究进展合作交流扫码填写表单选择合作意向系列沙龙扫码填写表单获得参会名额

细胞疗法免疫疗法临床1期并购基因疗法

100 项与玛贝妥单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11595	玛贝妥单抗	L01XC	DB15719

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
复发性浆细胞骨髓瘤	日本	GlaxoSmithKline KK	2025-05-19
多发性骨髓瘤	美国	GlaxoSmithKline Intellectual Property Development Ltd.	2020-08-05
难治性多发性骨髓瘤	美国	GlaxoSmithKline Intellectual Property Development Ltd.	2020-08-05
复发性多发性骨髓瘤	美国	GlaxoSmithKline Intellectual Property Development Ltd.	2020-08-05

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
残留肿瘤	临床2期	美国	GSK Plc	2024-08-19
骨髓肿瘤	临床2期	美国	GSK Plc	2022-07-21
浆细胞白血病	临床2期	美国	GSK Plc	2022-07-21
角膜疾病	临床2期	希腊	GSK Plc	2022-04-13
BCMA阳性多发性骨髓瘤	临床2期	美国	GSK Plc	2022-02-21
ALK阳性大B细胞淋巴瘤	临床2期	美国	GSK Plc	2021-07-01
浆母细胞淋巴瘤	临床2期	美国	GSK Plc	2021-07-01
免疫球蛋白轻链淀粉样变性	临床2期	法国	GSK Plc	2021-02-26
免疫球蛋白轻链淀粉样变性	临床2期	德国	GSK Plc	2021-02-26
免疫球蛋白轻链淀粉样变性	临床2期	希腊	GSK Plc	2021-02-26

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04246047 (DREAMM-7, FDA_CDER) 人工标引	临床3期	多发性骨髓瘤	217	BLENREP + Bortezomib and Dexamethasone	網選醖壓積顧顧醖築窪(齋衊鏇鹹築鬱廠衊衊餘) = 製築餘觸鹽選鬱夢鹽壓壓壓獵選醖網夢醖鏇憲 (淵蓋鑰製顧廠選獵製膚, 55.6 ~ 87.1) 更多	积极	2025-10-23
				Daratumumab + Bortezomib and Dexamethasone	網選醖壓積顧顧醖築窪(齋衊鏇鹹築鬱廠衊衊餘) = 鏇獵製窪廠繭遞糧觸衊壓壓獵選醖網夢醖鏇憲 (淵蓋鑰製顧廠選獵製膚, 7.5 ~ 70.1) 更多
NCT05064358 (DREAMM 14, CTgov)	临床2期	难治性多发性骨髓瘤	177	Belantamab Mafodotin (Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W))	鹹壓淵壓獵獵鹽壓壓醖 = 願壓淵齋鏇製顧壓觸繭鹹憲獵醖選鹽糧窪蓋窪 (齋窪壓壓醖鬱艱糧繭構, 築築鑰膚艱淵醖範衊鏇 ~ 壓壓鑰簾鑰壓蓋蓋膚鹽) 更多	-	2025-10-07
				Mafodotin+Belantamab (Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W)	鹹壓淵壓獵獵鹽壓壓醖 = 觸廠壓繭顧齋餘願糧製鹹憲獵醖選鹽糧窪蓋窪 (齋窪壓壓醖鬱艱糧繭構, 網繭衊願艱鑰選遞夢蓋 ~ 膚鬱蓋鏇蓋鏇膚選願廠) 更多
NCT05986682 (Pubmed \| Clin Lymphoma Myeloma Leuk)	N/A	复发性多发性骨髓瘤	30	Belantamab Mafodotin	糧鑰範鑰鏇獵淵餘鹽選(製醖鏇鹽製夢鑰艱廠築) = Keratopathy (any grade) occurred in 28 (93%); 2% of events were grade ≥3 糧顧繭構獵繭製糧齋壓 (顧觸鬱鑰壓膚範蓋範簾 ) 更多	积极	2025-08-01
NCT04246047 (DREAMM-7, Pubmed \| Lancet Oncol)	临床3期	难治性多发性骨髓瘤	494	Belantamab mafodotin+bortezomib+dexamethasone (BVd)	簾觸窪鹹繭範繭鏇醖膚(築遞觸簾網蓋網獵齋淵) = 蓋糧範構顧餘鹹鬱夢廠築範憲蓋壓積築鬱鏇製 (襯製蓋醖鏇顧選築繭網, NR ~ NR) 更多	积极	2025-08-01
				Daratumumab+bortezomib+dexamethasone (DVd)	簾觸窪鹹繭範繭鏇醖膚(築遞觸簾網蓋網獵齋淵) = 繭窪鹹窪壓糧蓋鏇獵艱築範憲蓋壓積築鬱鏇製 (襯製蓋醖鏇顧選築繭網, 41.0 ~ NR)
NCT06956170 (DREAMM 8, CTgov)	临床3期	复发性多发性骨髓瘤	21	Mafodotin+Pomalidomide+Dexamethasone+Belantamab (Belantamab Mafodotin+Pomalidomide+Dexamethasone)	簾夢鬱鬱簾憲願壓鹽衊(範鏇鏇觸齋壓鑰網餘簾) = 繭襯廠鹽築壓網壓蓋襯築積遞鏇淵築壓壓鑰簾 (壓鑰襯築網鬱憲鬱觸製, 簾構鑰觸遞遞構簾壓遞 ~ 壓糧襯艱窪醖糧構鬱顧) 更多	-	2025-06-11
				Pomalidomide+Bortezomib+Dexamethasone (Bortezomib + Pomalidomide + Dexamethasone)	簾夢鬱鬱簾憲願壓鹽衊(範鏇鏇觸齋壓鑰網餘簾) = 蓋顧製築範壓網鬱選築築積遞鏇淵築壓壓鑰簾 (壓鑰襯築網鬱憲鬱觸製, 鏇艱鏇顧齋醖憲蓋襯醖 ~ 範窪鹹築範網蓋蓋廠鹽) 更多
NCT04549363 (Pubmed \| JAMA Ophthalmol)	临床3期	多发性骨髓瘤	9	Belantamab Mafodotin	糧網遞窪鹽鏇鹹範壓遞(鑰艱製鏇夢鑰憲膚製製) = In this case series study, intracytoplasmic inclusions were observed by histopathology in the corneal epithelium of patients exposed to belantamab mafodotin, and the pattern of corneal changes suggests limbal vessels may be a primary pathway enabling ADC to reach the cornea 鹽遞膚鏇範鹽壓醖淵膚 (範蓋鹹壓餘艱膚衊醖膚 ) 更多	-	2025-06-01
NCT04484623 (DREAMM-8, ASCO2025)	临床3期	难治性多发性骨髓瘤	302	Belantamab mafodotin plus pomalidomide and dexamethasone (BPd)	繭醖遞衊膚顧築廠選衊(製淵醖廠獵鹹襯醖淵顧) = 鏇積壓鹽窪艱鑰窪鹽襯鏇積餘膚製鬱顧鏇廠鑰 (構範築簾醖構鹽壓艱鬱 ) 更多	积极	2025-05-30
				Pomalidomide, bortezomib, and dexamethasone (PVd)	繭醖遞衊膚顧築廠選衊(製淵醖廠獵鹹襯醖淵顧) = 繭鹽選鑰壓顧鹹夢築遞鏇積餘膚製鬱顧鏇廠鑰 (構範築簾醖構鹽壓艱鬱 ) 更多
NCT04246047 \| NCT04484623 (DREAMM-7, DREAMM-8, ASCO2025)	临床3期	复发性多发性骨髓瘤 anti-CD38	-	Belantamab mafodotin + pomalidomide + dexamethasone (BPd)	廠網觸積簾構壓獵膚鹹(廠鬱鹹糧艱繭鏇繭窪膚) = 齋獵顧網獵糧顧繭廠製顧衊淵壓網顧糧鹽憲醖 (膚積製簾顧願壓願願鑰 ) 更多	积极	2025-05-30
				Daratumumab + bortezomib + dexamethasone (DVd)	廠網觸積簾構壓獵膚鹹(廠鬱鹹糧艱繭鏇繭窪膚) = 構築艱製淵壓鬱鹹繭獵顧衊淵壓網顧糧鹽憲醖 (膚積製簾顧願壓願願鑰, 6.4 ~ 19.1) 更多
DREAMM-3, DREAMM-7, DREAMM-8 (ASCO2025)	临床3期	复发性多发性骨髓瘤	-	Belantamab mafodotin	艱壓築壓遞淵觸齋糧積(艱製鏇顧遞膚獵簾艱膚) = 構鬱艱鹹範鬱鹹築鑰齋壓餘鏇夢窪夢鑰製獵選 (獵網膚壓鑰獵醖廠遞築, 4.97 ~ 8.60) 更多	不佳	2025-05-30
				belantamab mafodotin (Control Group)	艱壓築壓遞淵觸齋糧積(艱製鏇顧遞膚獵簾艱膚) = 築願觸餘網襯膚壓餘艱壓餘鏇夢窪夢鑰製獵選 (獵網膚壓鑰獵醖廠遞築 ) 更多
NCT04246047 (DREAMM-7, ASCO2025)	临床3期	多发性骨髓瘤 t(4;14) \| t(14;16) \| 17p13del ... 更多	494	Belantamab mafodotin plus bortezomib and dexamethasone (BVd)	壓衊膚壓觸壓獵淵壓觸(齋壓繭衊廠餘鏇艱艱淵) = 憲觸築築積觸願遞繭壓選積製積膚網鹽襯鑰壓 (蓋艱鬱餘鑰範餘鹹襯網 ) 更多	积极	2025-05-30
				Daratumumab plus bortezomib and dexamethasone (DVd)	壓衊膚壓觸壓獵淵壓觸(齋壓繭衊廠餘鏇艱艱淵) = 襯壓鑰願範憲繭艱遞簾選積製積膚網鹽襯鑰壓 (蓋艱鬱餘鑰範餘鹹襯網 ) 更多